# 21 CFR § 814.2: Purpose

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-814.2

## Section

- **Citation:** 21 CFR § 814.2
- **Heading:** Purpose
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES > PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES > Subpart A—General

## Text

The purpose of this part is to establish an efficient and thorough device review process—
(a) To facilitate the approval of PMA's for devices that have been shown to be safe and effective and that otherwise meet the statutory criteria for approval; and
(b) To ensure the disapproval of PMA's for devices that have not been shown to be safe and effective or that do not otherwise meet the statutory criteria for approval. This part shall be construed in light of these objectives.

## Nearby sections

- [21 CFR § 814.1 § 814.1 Scope.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.1.md)
- [21 CFR § 814.2 § 814.2 Purpose.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.2.md)
- [21 CFR § 814.3 § 814.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.3.md)
- [21 CFR § 814.9 § 814.9 Confidentiality of data and information in a premarket approval application (PMA) file.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.9.md)
- [21 CFR § 814.15 § 814.15 Research conducted outside the United States.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.15.md)
- [21 CFR § 814.17 § 814.17 Service of orders.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.17.md)
- [21 CFR § 814.19 § 814.19 Product development protocol (PDP).](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.19.md)
- [21 CFR § 814.20 § 814.20 Application.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.20.md)
- [21 CFR § 814.37 § 814.37 PMA amendments and resubmitted PMAs.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.37.md)
- [21 CFR § 814.39 § 814.39 PMA supplements.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.39.md)
- [21 CFR § 814.40 § 814.40 Time frames for reviewing a PMA.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.40.md)
- [21 CFR § 814.42 § 814.42 Filing a PMA.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.42.md)
- [21 CFR § 814.44 § 814.44 Procedures for review of a PMA.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.44.md)
- [21 CFR § 814.45 § 814.45 Denial of approval of a PMA.](https://www.frixlaw.com/law-library/statutes/ecfr-21-814.45.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-814.2. Check the current official text before relying on it. Not legal advice.